Efficacy of Topical Lidocaine to Decrease Discomfort With Intranasal Midazolam Administration

NCT02396537 | Completed Results DMC

• 1 other identifier: F130917005
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to establish whether premedication with topical lidocaine would reduce the pain associated with IN midazolam administration in children. The study was designed to be a double-blinded, randomized, placebo-controlled trial performed in an urban, academic pediatric emergency department.

Conditions

Pain

Keywords

Children; Midazolam; Lidocaine; Intranasal

Outcome Measures

Primary Outcomes (1)

• Discomfort With Intranasal Midazolam Administration

  subject self-reports pain with intranasal midazolam utilizing the Wong-Baker FACES Pain Scale. This scale is a well-established ordinal pain scale for pediatric patients. It is one score (no subscales), with a minimum score of 0 (signifying "No Hurt") and a maximum score of 10 ("Hurts Worst"). Values between include 2 ("Hurts Little Bit"), 4 ("Hurts Little More"), 6 ("Hurts Even More"), and 8 ("Hurts Whole Lot."). Children indicate one value/answer. Thus, a higher score indicates a worse outcome (more pain).

  immediately after administration of intranasal midazolam

Study Arms (2)

Intranasal Lidocaine

EXPERIMENTAL

Patient to receive 4% lidocaine intranasally prior to midazolam

Drug: Lidocaine; Drug: Midazolam

Intranasal 0.9% saline

PLACEBO COMPARATOR

Patient to receive 0.9% Saline intranasally prior to midazolam

Drug: Midazolam; Drug: 0.9% Saline

Interventions

Lidocaine DRUG

Administered intranasally prior to Midazolam administration.

Also known as: Xylocaine

Intranasal Lidocaine

Midazolam DRUG

Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.

Also known as: Versed

Intranasal 0.9% saline; Intranasal Lidocaine

0.9% Saline DRUG

Administered intranasally prior to Midazolam administration.

Intranasal 0.9% saline

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ages 6-12
• Previously healthy
• Attending physician concludes that the patient would benefit from administration of an anxiolysis medication prior to a minor procedure

You may not qualify if:

• Moderate to severe asthma or other chronic lung disease
• Co-morbid conditions including cerebral palsy, developmental delay, or other chronic illness deemed by the Attending physician to be unsafe to receive anxiolysis with Versed.
• Any child presenting with a life-threatening condition.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Related Publications (1)

• Smith D, Cheek H, Denson B, Pruitt CM. Lidocaine Pretreatment Reduces the Discomfort of Intranasal Midazolam Administration: A Randomized, Double-blind, Placebo-controlled Trial. Acad Emerg Med. 2017 Feb;24(2):161-167. doi: 10.1111/acem.13115. Epub 2017 Jan 30.

  PMID: 27739142 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Midazolam; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Christopher Pruitt
• Organization: University of Alabama at Birmingham

cpruitt@peds.uab.edu

2056389587

Study Officials

• David Smith, MD

  UAB Department of Pediatrics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergency Medicine Faculty Advisor

Study Record Dates

• First Submitted: March 11, 2015
• First Posted: March 24, 2015
• Study Start: January 1, 2014
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 23, 2017
• Results First Posted: February 23, 2017

Record last verified: 2017-01